BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIERPRO

    MDR report key: 12016404 · Received June 17, 2021

    Report

    Report Number
    12016404
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 26, 2021
    Report Date
    May 28, 2021
    Manufacturer
    SVS LLC
    Product Code
    GDY
    UDI-DI
    00818566010582
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CIRCULATOR PASSED SCRUB TECH A PACK OF LAP SPONGES USING STERILE TECHNIQUE. WHEN SCRUB STARTED TO COUNT THE LAPS, SHE NOTICED A HAIR BETWEEN TWO OF THEM. TECH HANDED THE LAPS BACK TO CIRCULATOR AND REMOVED HER OUTER GLOVES. TECH DONNED NEW OUTER GLOVES. PACKAGING AND LAPS SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912082 PREMIERPRO GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE GDY SVS LLC X8435 CBI11-05 00818566010582

    Patients

    Seq Age Sex Outcome Treatment
    1 21170 DA